previously treated genetically high-risk of the GENUINE phase 3 study
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1 Ublituximab and ibrutinib for previously treated genetically high-risk chronic lymphocytic leukemia: results of the GENUINE phase 3 study Jeff P. Sharman, 1, 17 Danielle M. Brander, 2 Anthony Mato, 3 Suman Kambhampati, 4 John M. Burke, 5, 17 Frederick Lansigan, 6 Marshall T. Schreeder, 7 Scott D. Lunin, 8 Nilanjan Ghosh, 9 Alexander Zweibach, Mikhail Shtivelband, 11 Patrick M. Travis, 12 Jason Chandler, 13 Kathryn S. Kolibaba, 14, 17 Peter Sportelli, 15 Hari P. Miskin, 15 Michael S. Weiss, 15 and Ian W. Flinn 16 1 Willamette Valley Cancer Institute, Springfield, OR; 2 Duke University Medical Center, Durham, NC; 3 Center for CLL, University of Pennsylvania, Philadelphia, PA; 4 Sarah Cannon Research Institute at Research Medical Center, University of Kansas Cancer Center, Kansas City, KS; 5 Rocky Mountain Cancer Centers, Aurora, CO; 6 Dartmouth-Hitchcock Medical Center, Lebanon, NH; 7 Clearview Cancer Institute, Huntsville, AL; 8 Florida Cancer Specialists, Sarasota, FL; 9 Levine Cancer Institute, Charlotte, NC; 10 Cancer Care Centers of South Texas, New Braunfels, TX; 11 Ironwood Cancer and Research Center, Chandler, AZ; 12 Highlands Oncology Group, Fayetteville, AR; 13 West Cancer Center, Memphis, TN; 14 Compass Oncology, Vancouver, WA; 15 TG Therapeutics, Inc., New York, NY; 16 Sarah Cannon Research Institute, Nashville, TN; 17 US Oncology Research, Woodlands, TX 10, 17
2 Introduction Despite the introduction of ibrutinib and other targeted agents, patients with CLL continue to relapse and complete remissions are rare Patients with high risk cytogenetic features still have the poorest outcome on ibrutinib Improving ibrutinib therapy through combinations remains a high priority Byrd et al, Blood
3 Single agent activity observed in rituximab refractory patients 1 Phase 2 study in combination with ibrutinib: ORR ~88% (investigator assessed) 2 90 minute infusion times 1 O Connor et al, BJH 2016; 2 Sharman et al, BJH
4 UTX-IB-301 (GENUINE) Study Design Open-label, multicenter, randomized, Phase III study in relapsed or refractory highrisk CLL Originally designed with ORR and PFS as co-primary endpoints Due to enrollment challenges, lowered target enrollment and removed PFS as a co-primary Response assessments occurred at Week 8, 16, and 24, and every 12 weeks thereafter 4
5 Study Endpoints Primary endpoint: Overall Response Rate as assessed by Independent Central Review Committee (IRC) by iwcll (Hallek 2008) criteria Evaluated when all enrolled patients had at least two efficacy evaluations Secondary endpoints: CR rate MRD negativity PFS, DOR, TTR Safety Statistical Assumptions: 120 patients required to have 90% power to detect an absolute difference in ORR of approximately 30% 5
6 Key Eligibility Criteria Age 18 y Relapsed/refractory CLL requiring treatment Centrally confirmed presence of 17p del, 11q del, and/or TP53 mut Measurable disease ECOG 2 No history of transformation of CLL No prior BTK inhibitor therapy 6
7 Patient Disposition 126 patients randomized, 9 never treated 100% were either: del17p, del11q or TP53 64% of UTX + IB patients and 66% of IB Alone patients were del17p or TP53 mut 36% of UTX + IB patients and 34% of IB Alone patients were del11q only Median Follow up: 11.4 mo Data Cutoff: February 15, % off study from disease progression or death (n=7) UTX + IB (n=64) del17p: 47% del11q: 50% TP53mut: 42% Discontinued study (n=15) AE (2) Physician decision (3) Withdrew consent (1) Other (2) Treated (n=59) 75% ongoing on study (n=44) Randomized (n=126) IB Alone (n=62) del17p: 47% del11q: 47% TP53mut: 47% Treated (n=58) 55% ongoing on study (n=32) ITT-population Treated and safety population Discontinued study (n=26) AE (5) Physician decision (4) Withdrew consent (4) Other (2) 19% off study from disease progression or death (n=11) 7
8 Demographics Characteristic, % (n) Ublituximab + Ibrutinib n=64 Ibrutinib n=62 Mean age, years (range) 67 (43-87) 67 (51-86) Mean time from diagnosis to randomization, years (range) 6.6 (3 mos 22 yrs) 6.5 (3 mos 20 yrs) Male 44 (69%) 46 (74%) ECOG performance status at baseline Rai stage III-IV, % 32 (50%) 26 (42%) IGHV unmutated, % 51 (80%) 51 (82%) Bulky disease at baseline ( 5cm) 29 (45%) 16 (26%) Number of prior lines of therapy, median (range) 3 (1-7) 3 (1-8) Most common prior regimens FC ± Rituximab BR Rituximab Obinutuzumab ± Chlorambucil Idelalisib ± Rituximab 30 (47%) 27 (42%) 54 (84%) 5 (8%) 5 (8%) 29 (47%) 29 (47%) 57 (92%) 4 (6%) 4 (6%) 8
9 Safety: Adverse Event Summary ( 10%) Ublituximab + Ibrutinib (N=59) Ibrutinib (N=58) All Grades Grade 3/4 All Grades Grade 3/4 Infusion reaction 54% 5% - - Diarrhea 42% 3% 40% 3% Fatigue 27% - 33% 2% Insomnia 24% - 10% 2% Nausea 22% - 21% 2% Headache 20% - 28% 2% Arthralgia 19% 2% 17% - Cough 19% - 24% - Abdominal Pain 15% - 9% - Stomatitis 15% 2% 9% 2% Upper Respiratory Infection 15% - 12% 2% Dizziness 15% - 22% 2% Contusion 15% - 29% - Anemia 14% 5% 17% 7% Peripheral Edema 10% - 21% - Adverse Events <10% of Special Interest Pneumonia 5% 0% 9% 5% Atrial Fibrillation 3% 3% 5% 2% Febrile Neutropenia 3% 3% 2% 2% 9
10 Safety: Key Laboratory Abnormalities Ublituximab + Ibrutinib (N=59) Any Grade Grade 3 n (%) n (%) Any Grade n (%) Ibrutinib (N=58) Grade 3 n (%) ALT elevation 1 (2%) - 2 (3%) 1 (2%) AST elevation 1 (2%) - 2 (3%) 1 (2%) Anemia 8 (14%) 3 (5%) 10 (17%) 4 (7%) Neutropenia 13 (22%) 5 (9%) 7 (12%) 6 (10%) Thrombocytopenia 8 (14%) - 6 (10%) 2 (3%) Blood creatinine increase 5 (9%) - 1 (2%) - Blood uric acid increase 5 (9%) - 1 (2%) - 10
11 Efficacy: IRC Assessed ORR, CR, & MRD-Negativity 7% CR Best Overall Response Rate (ORR) (p < 0.001) 78% MRD-Negative (Peripheral Blood) 19% (p < 0.01) 71% PR 45% 45% PR Patients evaluable for MRD included those enrolled >4 months prior to data cutoff 2% ITT ORR: p < 0.01 N=59 Ublituximab + Ibrutinib N=58 Ibrutinib N=53 Ublituximab + Ibrutinib N=53 Ibrutinib 11
12 Best Percent Change in Nodal Size 0% Ibrutinib 0% Ublituximab + Ibrutinib -25% -25% -50% -50% -75% -75% -100% 52% (30/58) had >75% decrease 66% (39/59) had >75% decrease -100% 12
13 Absolute Lymphocyte Count (K/uL) Lymphocytosis Absolute Lymphocyte Count median (interquartile range) Ibrutinib Alone Ublituximab + Ibrutinib Ublituximab + IB (CD20 Refractory) Cycles 13
14 Efficacy: Impact of including PR-L on ORR 5% Remain PR-L Best Possible Overall Response Rate (ORR) Including Active PR-L patients 83% 7% CR (p < 0.01) 71% PR 59% 14% Remain PR-L 78% ORR (iwcll 2008) 45% PR 45% ORR (iwcll 2008) N=59 Ublituximab + Ibrutinib N=58 Ibrutinib 14
15 Proportion of Progression-Free Efficacy: IRC-Assessed PFS Ubli + IB IB Alone 59 (0) 58 (0) 41 (2) 35 (6) Time to Event (month) 25 (6) 16 (9) 9 (7) 8 (11) 0 (7) 1 (11) 15
16 Conclusions The GENUINE study met its primary endpoint, demonstrating that ublituximab in combination with ibrutinib yields superior ORR to ibrutinib alone in high-risk CLL ORR 45% (IB) vs. 78% (UTX+IB), p<0.001 CR rate 7% vs. 0 (secondary endpoint) MRD- rate 19% vs 2% (secondary endpoint), p<0.01 Secondary endpoint shows trend (HR=0.559) in improvement of PFS however not statistically significant at time of analysis With the exception of infusion related reactions, ublituximab did not alter the safety profile of ibrutinib monotherapy 16
17 Acknowledgements The authors would like to thank the patients and their families, and all participating investigators: USA: Ian Flinn, Danielle Brander, Anthony Mato, Suman Kambhampati, John Burke, Frederick Lansigan, Marshall Schreeder, Scott Lunin, Alexander Zweibach, Jason Chandler, Mikhail Shtivelband, Nilanjan Ghosh, Patrick Travis, Bipin Amin, Charles Farber, David Wright, Habte Yimer, Herbert Eradat, Jason Melear, Jeff Sharman, John Pagel, Kenneth Miller, Michael Boxer, Michael Guarino, Mohit Narang, Noel Laudi, Russell Baur, Subhash Sharma, Thomas Sunnenberg, Vincent Hansen, Adam Olszewski, Andrew Bernstein, Anthony Gulati, Burke Brooks, David Riseberg, Dhatri Kodali, Gilles Lugassy, James Essell, Joseph Leach, Kathleen Phelan, Leonard Klein, Mazen Khalil, Nashat Gabrail, Ndegwa Njuguna, Robert Gordon, Robert Jacobson, Robert Siegel, Sharad Jain, Spencer Shao, Stefano Tarantolo, Sunil Babu, Suzanne Fanning, Yuvraj Choudhary. ISRAEL: Gilles Lugassy This study was funded by TG Therapeutics, Inc. 17
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